What side effects are associated with this type of intervention?

Common treatments for TBI that focus on emotional and psychological support, such as animal-assisted therapy, generally have minimal physical side effects. However, potential psychological side effects can include emotional attachment to the therapy animal, which might lead to distress if the animal is not present. Additionally, there may be risks of allergies or fear of animals in some patients. Overall, these therapies are considered safe and beneficial for improving patient engagement and emotional well-being.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Traumatic Brain Injury (TBI) that focus on enhancing patient engagement through emotional and psychological support, similar to Animal-Assisted Therapy. Most FDA-approved treatments for TBI are pharmacological and aim to address the physical and cognitive symptoms rather than emotional or psychological support. Therefore, while Animal-Assisted Therapy shows promise in improving patient engagement and emotional well-being, it remains an innovative approach that is still under investigation.

What other types of research exist?

Promising novel alternatives to Animal-Assisted Therapy for TBI patients include: 1) Music Therapy, which may improve communication skills and social interaction; 2) Therapeutic Horseback Riding, which can enhance cognitive, social, and motor functions; 3) Mind-Body Therapies such as yoga and Qigong massage, which have shown benefits in improving sensory regulation and social interaction; and 4) Videoconference-based group treatments, which increase access to healthcare and have shown high compliance and satisfaction among patients.

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Animal Assisted Therapy for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc.)

Age at the time of screening: 4-21 years old

Must not have

Disease: Participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study completion - an average of 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether having dogs in therapy sessions helps children with brain injuries stay engaged in their rehabilitation. The goal is to see if this approach makes therapy more effective and enjoyable for these children.

Who is the study for?

This trial is for children and adolescents aged 4-21 who are in inpatient rehab after a brain injury like TBI or infection. They must be responsive (Rancho score >2), have consent from guardians, and assent to participate. It's not for those with communicable diseases, immune issues, dog allergies/fears, history of animal abuse, or developmental delays before the injury.

What is being tested?

The study tests if including dogs in physical and occupational therapy sessions improves engagement during rehabilitation for pediatric brain injuries. It uses a crossover design where each patient experiences both standard care and animal-assisted therapy to see which works better.

What are the potential side effects?

Since this trial involves animal-assisted therapy rather than medication, traditional side effects aren't expected. However, there might be risks related to interactions with animals such as stress or discomfort if the child has underlying fears or allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am admitted for rehab due to a brain injury like TBI, tumor, or infection.

Select...

I am between 4 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not on contact precautions, do not have a communicable disease, and my immune system is not compromised.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study completion - an average of 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study completion - an average of 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion - an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Engagement rating.

Patient Participation/engagement

Secondary study objectives

Automated mood assessment

Objective mood assessment

Patient-reported mood

+2 more

Other study objectives

Anthropomorphism

Patient-animal rapport

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

animal assisted therapy

Group II: ControlActive Control1 Intervention

Treatment as usual

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) often include therapies that enhance patient engagement through emotional and psychological support, such as Animal-Assisted Therapy. These therapies work by providing emotional comfort, reducing anxiety, and improving mood, which can significantly enhance a patient's willingness to participate in and adhere to rehabilitative exercises. This increased engagement is crucial for effective rehabilitation, as it can lead to more consistent practice of physical and occupational therapies, ultimately improving functional outcomes and quality of life for TBI patients.

Guidelines for head injury: their use and limitations.